A Consideration of H1N1/09pdm and New Variant H3N2/13 as Agents for Human Challenge Trials
Within the field of influenza research, there is becoming an increasingly large place for Human or Viral Challenge Trials (HCT). Challenge trials allow for the direct measurement of vaccine or drug performance against a manufactured virus inoculated into healthy volunteers. Such studies can circumvent the need for large scale field trials in early phase, providing high quality efficacy and safety data.
Owing to the heterotypic nature of influenza it is necessary that pharma companies or clinical research organisations work to develop a broad menu of strains as challenge agents. The use of cGMP manufactured H1 or H3 viruses in such trials can emulate high incidence disease, negating the limitations of prevalence and seasonality of disease in the wild.